Variations Addendum For Human And Veterinary Medicines

Variations Addendum For Human And Veterinary Medicines

This document provides recommendations to applicants wishing to submit applications for the variation of human and veterinary medicines. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. This guideline will be available from the office of the Chief Executive Officer and the website after consolidation of all comments


Download Version 5 (2.08)

Date updated

2022 Sep

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File Type: pdf
Category: Guideline
Unit: General ECTD & human medicines, Veterinary medicines